Portable MRI for Pediatric Hypoxic Ischemic Brain Injury (pMRI for pHIBI)

Ultralow-Field Portable MRI for Detection of Pediatric Hypoxic Ischemic Brain Injury

This study will evaluate the sensitivity and specificity of low field portable MRI (pMRI) for detection of hypoxic ischemic brain injuries in pediatric patients compared to clinically obtained neuroimaging to define pediatric diagnostic limitations and to determine the diagnostic capabilities of this neuroimaging modality following optimization of image acquisition. The results of this study will help determine optimal clinical implementation opportunities in pediatric patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Brain Injuries; Hypoxia, Brain; Acute Brain Injury; Trauma, Brain; Ischemia, Brain
• Intervention / Treatment: Device: Portable MRI; Other: Scavenged Sample Collection

Detailed Description

Standard brain magnetic resonance imaging (MRI) is the gold-standard to diagnose acute ischemic brain injuries; however, it is not always feasible to obtain this standard MRI due to risks and contraindications. Some of the most common risks can include transport to the radiology department, especially with critically ill patients on life-saving medical devices, exposure to ionizing radiation, and contraindications can include incompatible surgical hardware in patients' bodies, amongst others.

Our institution has an FDA-cleared portable MRI (pMRI) by Hyperfine Research, Inc. (HRI). This device addresses many of the conventional MRI challenges by:

1. Operating at very low magnetic field strengths strength (less than 0.2 T or approximately 10 times less than the field strength of conventional devices) and eliminating the need for special rooms or shielding. Family members and staff can remain at the patient's bedside.
2. Minimizing conditions such as claustrophobia and anxiety with an open concept, transparent "helmet" to rest the head in during the exam.
3. Portable and can maneuver through hospital environments and wheeled directly to a patient's bedside.
4. Noise levels are substantially lower than conventional MRI systems, so hearing protection is optional for the patient. The sounds are described as vibrations that produce rhythmic tones.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica S Wallisch, MD; Phone Number: (816) 234-3041; Email: jwallisch@cmh.edu
• Study Contact Backup: Name: Allison Scott, RN, CCRC; Phone Number: (913) 515-7535; Email: abscott@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Patients hospitalized in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
• Ages 0-17 years at study enrollment
• Acute neurologic deficit suspected secondary to Hypoxic Ischemic Brain Injury (HIBI) or patients at high risk for HIBI

Exclusion Criteria

• Pregnancy

• Active implants such as

  • Pacemaker
  • Implanted defibrillator
  • Implanted insulin pump
  • Deep brain stimulator
  • Vagus nerve stimulator
  • Cochlear implant
  • Programmable shunt
• MRI incompatible surgical hardware (e.g., staples, screws, etc.)
• Metal-containing tattoos or permanent make-up on head or neck
• Suspected metal in eye, e.g.,
• Former or current welders, metal workers, or individuals with a metal injury
• Metal shrapnel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable MRI Arm; All subjects enrolled with be assigned to Arm 1	Device: Portable MRI; Enrolled subjects will undergo a portable, ultralow-field MRI (pMRI) at the bedside in the ICU location within +/- 24 hours of a clinically obtained, conventional MRI and/or head CT; Other: Scavenged Sample Collection; Remaining blood or cerebrospinal fluid samples from clinical testing will be scavenged at timepoints correlating to the radiology imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the sensitivity and specificity of pMRI for detection of acute pediatric focal ischemic brain injuries.	Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI. Compare detection rates and severity of ischemia and cerebral edema by pMRI vs conventional MRI to determine sensitivity and specificity.	During intensive care admittance, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate the sensitivity and specificity of pMRI for detection of acute pediatric global hypoxic-ischemic brain injuries	Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional MRI that demonstrates acute global hypoxic-ischemic brain injury as read by a clinical neuroradiologist. Compare detection rates and severity of acute global hypoxic-ischemic brain injury by pMRI vs conventional MRI to calculate sensitivity and specificity.	During intensive care admittance, an average of 1 month
Establish the sensitivity and specificity of pMRI relative to head CT for detection of cerebral edema and ischemic brain injury in critically ill patients deemed unstable for standard MRI.	Perform pMRI on pediatric ICU patients within +/- 24 hours of a clinically obtained, conventional head CT obtained for acute neurologic changes. Compare detection rates and severity of cerebral edema and ischemia by pMRI vs head CT to establish sensitivity and specificity.	During intensive care admittance, an average of 1 month

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Jessica S Wallisch, MD, Children's Mercy Kansas City

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries, Traumatic; Stroke; Brain Injuries; Brain Ischemia; Hypoxia, Brain
• Other Study ID Numbers: STUDY00003934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified IPD will be made available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No